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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE LIFEBAND; CARDIAC RESUSCITATOR BAND
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ZOLL CIRCULATION AUTOPULSE LIFEBAND; CARDIAC RESUSCITATOR BAND Back to Search Results
Model Number MODEL 100
Medical Device Problem Codes Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/20/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the lifeband in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
Event or Problem Description
During device check, the lifeband (lot # unknown) sheared at the place where the lifeband enters the platform.No patient involvement.
 
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Brand Name
AUTOPULSE LIFEBAND
Common Device Name
CARDIAC RESUSCITATOR BAND
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
MDR Report Key11988567
Report Number3010617000-2021-00517
Device Sequence Number4408876
Product Code DRM
UDI-Device Identifier10849111001691
UDI-Public10849111001691
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K112998
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0706-01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/21/2021
Initial Report FDA Received Date06/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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